Therapy-related leukemia is a late complication of treatment with cytotoxic drugs and/or irradiation. It is a distinctive clinicopathological and cytogenetic syndrome that is usually fatal. One of the special features of this Program Project is that the four individual projects are absolutely dependent upon patient material, since most of the questions to be addressed arise from the nature of individual patient responses to chemotherapy or radiotherapy. That is, why do some patients develop secondary leukemia and others not? The Patient Access, Data Management, Statistical Analysis, and Tissue Culture Core has the four-fold missions of specimen acquisition and storage, data management, statistical collaboration, and the generation of Epstein-Barr virus (EBV)-transformed lymphoblastoid cell lines. These functions are critical to the successful completion of the proposed investigations in each of the four projects and necessary to support and link together the results that come from the various laboratories. In this way, unique patient resources are shared in the most productive manner. This Core is highly integrated with all 4 projects, and collaborative work has resulted in 23 publications from this Core during the past grant period. To provide an orderly access to patient material and to maintain records, we propose to continue our Core component to manage these functions as it has for the past 15 years. In addition to patient enrollment, chart review, and specimen collection, support for database coordination and security and for statistical consultation are included in this core. The Core insures that appropriate bone marrow and blood specimens are obtained prospectively for the Cancer Cytogenetics Laboratory from new patients with AML de novo, primary MDS, or t-MDS/t-AML. Research subjects sign Informed Consent forms that are reviewed and approved by the University of Chicago Institutional Review Board annually. After collection, the clinical specimens are logged in, processed appropriately, and then either stored or delivered to the individual projects. Requests from each project PI for specific clinical materials (normal or malignant blood or marrow cells, DNA from buccal swabs, or cell lines from specific patients or family members) are received by this Core. Requests from program investigators have the highest priority, but samples have also been shared with other cancer researchers both at the University of Chicago and elsewhere. The Core also has the responsibility for generating an immortalized, EBV-transformed lymphoblastoid cell line from each patient with a primary or therapy-related leukemia. Thus, both normal and malignant cells from each patient are stored in the Core facility. These resources allow us to study the non-malignant cells and germline DNA from both living and deceased patients with therapy-related leukemia. Buccal swabs are obtained from patients and stored as a back-up source of DNA for those cases where cell lines fail to grow. Patient confidentiality is protected in several ways. Data forms are kept in secure file cabinets. Case numbers are assigned, and names or initials are not used in publications. Research data are not placed in patients' medical records. Inventories of frozen cells as well as research data are maintained in confidential electronic files under password security. The database is automatically backed up on a daily basis; tapes are made and stored off site for further protection. There is no dial-in access to the database, and anti-virus screens are continuously employed on the network. Access to the database is restricted to 4 individuals in the Core. Each of these individuals, as well as all other clinical and laboratory research personnel likely to come into contact with any data or specimens involved in the Program, have completed the required course in Human Subjects Protection coordinated by the University of Chicago Institutional Review Board.